Bausch Health Documentation Analyst I (WA) in Bothell, Washington
Solta, a division of Bausch Health, is committed to improving patients quality of life by delivering sophisticated technology in simple, elegant designs, providing true aesthetic and therapeutic benefits. For more than a decade, we've been developing innovative treatment technologies to provide proven and effective aesthetic care options to consumers and physicians alike.
As required by law, Bausch Health provides a reasonable range of compensation for roles that may be hired in the US. Actual compensation is influenced by a wide array of factors including but not limited to skill set, level of experience, and specific office location. For this role, the range of starting pay for this role is $50K to $70K per year.
Principal Responsibilities and Duties:
Note: The following are meant to be representative but not necessarily all inclusive of the duties and responsibilities for this position title.
Administer the Agile Change Order, Manufacturing Change Order, and Deviation processes including initiation, checking, routing, releasing, implementing, and transferring to the ERP system
Coordinate with other disciplines to ensure change orders are complete and meet documentation requirements prior to routing
Coordinate with other disciplines to ensure change order implementation actions are complete; monitor and report on action status
Chair Change Control Board (CCB) meetings
Assist other disciplines with Agile tasks
Perform basic Agile administration tasks such as user administration
Ensure that documentation complies with GMP and regulatory requirements
Assist in development of new and revision of existing Agile processes
Additional duties as defined by supervisor
Experience, Education, Training, Skills, Traits:
Familiarity with FDA QSR and ISO 13485 principles, especially those regarding documentation, change control, and configuration management, a plus
Experience with Agile or other PLM systems a plus
Experience working in a regulated environment a plus
A self-motivated, self-directed and detail-oriented individual, able to work in a team and small company environment with minimal supervision.
Must have excellent work ethic, personal responsibility, initiative, and teamwork skills.
Effective verbal and written communication and interpersonal skills.
Proficient in the use of PC software (MS Word, Excel, etc.).
Language and Verbal Skills
Ability to read, analyze, and interpret governmental regulations, general business periodicals, professional journals, and technical procedures. Ability to write procedures, reports, and business correspondence in English. Ability to effectively present information and respond to questions from groups of managers, and internal customers. Ability to clearly and concisely convey project accomplishments, obstacles, issues, and project status.
Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
Analytical and Reading Skills
Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to read regulatory, technical and clinical literature and documents and extract important concepts.
- May be required to perform lifting tasks of up to 20 pounds for short durations. Duties of this job may involve sitting for extended periods of time. Duties also involve daily keyboard data entry. Specific vision abilities required by this job include close vision.
- Most work will be performed in an office environment. The noise level in the work environment is usually low to moderate.
- Solta Medical is committed to the health and safety of our employees. We expect that all employees will perform their responsibilities while maintaining a safe, cooperative, and productive work environment, thus ensuring the health and safety of themselves and others.
Benefits package includes a Comprehensive Medical (includes Prescription Drug), Dental, Vision, Health Savings Account with company contribution, Flexible Spending Accounts, 401(k) matching, 3-weeks paid time off plus 6 days paid sick time (unless a state or city-specific policy applies) to start (pro-rated for new hires), Employee Stock Purchase Plan, tuition reimbursement, parental leave, short-term disability, long-term disability, life insurance, accidental death & dismemberment insurance, 12 paid holidays (including floating holidays), Employee Assistance Plan, commuter benefit, recognition awards, voluntary benefits (including Identity Theft, Student Loan and Breast Milk Shipping), employee referral bonuses and employee discounts.
This position may be available in the following location(s): Bothell, Washington
Bausch Health Companies Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment regardless of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates collaboration.
If a candidate needs a reasonable accommodation/adjustment due to physical or mental health impairment for any part of the application process, they are encouraged to send their request to firstname.lastname@example.org or call 908-927-1400 and let us know the nature of the request and their contact information. Please be sure to include the job requisition number.
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To learn more please read Bausch Health's Job Offer Fraud Statement
Bausch Health is an EEO/AA employer M/F/D/V.
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